Abstract
Although the Starr-Edwards caged-ball valve remains a standard of comparison for more recently introduced prostheses, a substantial incidence of thromboembolic and hemorrhagic complications prompted our evaluation of the Hancock glutaraldehyde-fixed porcine xenograft. We have compared the results of 435 aortic valve replacements using the Starr- Edwards valve (SE-AVR), 515 mitral valve replacements (SE-MVR), and 121 double-valve replacements (SE-AVRMVR) with 251 aortic valve replacements using the xenograft aortic valve (X-AVR), 338 mitral valve replacements (X-MVR), and 88 double-valve replacements (X-AVR-MVR). The Starr- Edwards valves were used during the period 1963 through 1973 and the xenograft valves between 1971 and 1976. No significant differences in patient age, sex, or preoperative hemodynamic data were noted between comparable groups. All patients with Starr-Edwards valves received long-term anticoagulation while anticoagulants were used only for specific indications in patients with xenograft valves. Total follow up was 3944 patient years for the Starr-Edwards patients and 947 patient years for the xenograft patients. Hospital mortality was not significantly different for comparable groups: SE-AVR 6.9% vs. X-AVR 6.4%, SE-MVR 9.7% vs X-MVR 8.6%, and SE-AVR-MVR 7.5% vs. X-AVR-MVR 10.2%. Linearized mortality and morbidity data expressed as percent per patient- year are tabulated below. Pairs which differ significantly (p < .05) are italicized.
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